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Controlled Randomized Non-comparative Trial Assessing Active Transcranial Direct Current Stimulation [tDCS] on Left Dorsoleteral Prefrontal Cortex Versus Active tDCS Active on Right Orbitofrontal Cortex to Treat Unipolar Depression
The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.
Depressive disorders are one of the most frequent pathologies in psychiatry. The lifetime prevalence of the characterized depressive episode is indeed particularly high, between 16.6% in the United States and 24.1% in France. Because of this high prevalence, and because they constitute a pathology with a high risk of suicidal behavior (SC), depressive disorders are a major target of medical strategies for suicide prevention. In addition to suicidal ideation, impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behaviors, is recognized as being a major factor precipitating SCs. With a pilot, prospective, multicenter design, the perspectives of DEPIMPULSE include being able to develop an innovative therapeutic approach in the reduction of risky behaviors, in particular suicidal ideation, associated impulsivity, suicidal risk in patients suffering from depression, while improving our understanding of the behavioral aspects and associated cognitions. The treatment will be delivered during 5 consecutive days (D1 to D5). Baseline measures (D0) will be compared to those obtained after the treatment administration (last day of treatment (D5) and 2 weeks (+W2) and 1 month (+W4) after the end of treatment.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Besançon
Besançon, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Chenevier, GH Henri Mondor
Créteil, France
CHU de Montpellier
Montpellier, France
Start Date
September 1, 2023
Primary Completion Date
July 1, 2025
Completion Date
February 1, 2026
Last Updated
May 14, 2024
100
ESTIMATED participants
active tDCS stimulating left DLPFC
DEVICE
active tDCS stimulating right OFC
DEVICE
sham tDCS
DEVICE
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
NCT07025720
NCT07432438
Data Source & Attribution
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